An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane
Phase of Trial: Phase III
Latest Information Update: 21 Dec 2017
At a glance
- Drugs Eribulin (Primary) ; Vinorelbine
- Indications Advanced breast cancer
- Focus Pharmacokinetics; Registrational; Therapeutic Use
- Sponsors Eisai Co Ltd
- 29 Nov 2017 According to Eisai Co Ltd media release, the company announced today that the China Food and Drug Administration (CFDA) has accepted for review the resubmitted New Drug Application (NDA) for Eisais anticancer agent eribulin mesylate [eribulin, product name: Halaven(R)].
- 27 Jun 2017 According to Eisai Co Ltd media release, in alignment with Chinese regulations the company has withdrawn drug application for anticancer agent eribulin mesylate (Halaven) in China in order to submit additional documentation. The company will resubmit the NDA as soon as the additional documentation is prepared. NDA was submitted in July 2016 based on the data from this trial.
- 05 Aug 2016 Primary endpoint has been met. (Progression-Free Survival (PFS) of Eribulin Arm over the comparator treatment vinorelbine: Time to disease progression), as per Eisai media release.